MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA

Catalog Number 682245

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or samples were available to the quality team for evaluation, therefore, the nonconformance could not be verified.A device history record could not be evaluated as the lot number is unknown.The arterial cannula tube draw machine was reviewed and the machine parts that contact the catheter tubing are the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause part-off in the catheter tubing.The arterial cannula assembly machine was also reviewed.There is an automated vision inspection machine at the arterial cannula assembly machine, and it will auto reject any parts not meeting the lie distance requirement.If the catheter tubing is broken, its lie distance would most likely have failed and will automatically be rejected by the line.Based on the quality team's investigation, the root cause of this incident cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd¿ arterial cannula broke from the hub and backed out of the patient's vein during use.The following information was provided by the initial reporter: "a - line removed from patient and discarded as appeared intact.Following several minutes patient alerted staff to note that small tip of cannula just protruding from insertion site.Details of injury (to patient, carer or healthcare professional): no injury or harm.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).Cannula tip removed (less than 1cm).".

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12514398
• MDR Text Key: 272751255
• Report Number: 8041187-2021-00855
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1